Efficacy and Safety of RAZADYNE ER

Ar Efficacy1

RAZADYNE ER has been proven to help patients with mild to moderate dementia of the AD type maintain cognition and function. In most patients RAZADYNE ER is also well tolerated. Generally, adverse events were mild and temporary.4

RAZADYNE ER can help many patients stay engaged by:

  • Maintaining cognitive and functional abilities3

  • Helping patients help themselves
  • Offering convenient, once-daily dosing

Click the links to learn more about the clinical experience with RAZADYNE ER.

RAZADYNE ER: Helped many patients maintain cognition and function at home and in the community.

In a 6-month randomized, double-blind, placebo-controlled clinical trial, patients with mild to moderate dementia of the Alzheimer's type treated with RAZADYNE ER showed significant improvement in cognition compared with those treated with placebo. They also maintained their level of interaction, as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog/11). Patients treated with placebo generally declined in these areas.3

*"Activities of daily living" include eating, walking, using the restroom, bathing, grooming, dressing, physical performance, using common household appliances, conversation, tending to the home, managing personal belongings, travel, shopping, knowledge of current events, reading, and writing.

Ar Efficacy Efficacy2

Primary outcome measures were ADAS-cog/11 and the Clinician's Interview-Based Impression of Change—plus caregiver input. Observed case analysis shown at months 2, 3, and 6. At each of these observations, there was no statistically significant difference between the RAZADYNE and RAZADYNE ER formulations. Last observation carried forward (LOCF) shown at endpoint.1

† Results shown are from a 6-month, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study comparing the safety, tolerability, and efficacy of RAZADYNE ER with that of placebo in patients with mild to moderate Alzheimer's disease (AD). In the study, 965 patients were randomized and received at least 1 dose of placebo, RAZADYNE, or RAZADYNE ER. Results for patients treated with RAZADYNE are not shown.

Ar Efficacy Efficacy1

The Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) inventory was used as a secondary outcome measure. Observed case analysis shown at months 2, 3,and 6. At each of these observations, there was no statistically significant difference between the RAZADYNE and RAZADYNE ER formulations. LOCF shown at endpoint.1

"Activities of daily living" include eating, walking, using the restroom, bathing, grooming, dressing, physical performance, using common household appliances, conversation, tending to the home, managing personal belongings, travel, shopping, knowledge of current events, reading, and writing.

When they know something is wrong... Let them know RAZADYNE ER is well tolerated.

Listed below are some of the adverse events experienced by patients during RAZADYNE ER therapy from a pivotal study. The most frequent adverse events in the placebo-controlled trial with dose escalation every 4 weeks occurring in at least 5% of patients receiving RAZADYNE ER and at least twice the rate of placebo.4

4
  • RAZADYNE ER [Prescribing information]. Titusville, NJ:Ortho-McNeil Neurologics, Inc.;2006.

IMPORTANT SAFETY INFORMATION

Anesthesia—Cholinesterase inhibitors, such as galantamine hydrobromide, are likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia.

Cardiovascular events—Because of their pharmacologic action, cholinesterase inhibitors have vagotonic effects on the sinoatrial and atrioventricular (AV) nodes, leading to bradycardia and AV block. These actions may be particularly important to patients with supraventricular cardiac conduction disorders or to patients taking other drugs concomitantly that significantly slow heart rate. In clinical trials, galantamine hydrobromide was associated with more frequent reports of bradycardia and syncope vs placebo.

Gastrointestinal—Cholinesterase inhibitors may increase gastric acid secretion. Patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with an increased risk of developing ulcers, eg, those with a history of ulcer disease or patients using concurrent nonsteroidal anti-inflammatory drugs.

Genitourinary—Cholinesterase inhibitors may cause bladder outflow obstruction.

Neurological conditions—Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. In clinical trials, there was no increase in the incidence of convulsions with galantamine hydrobromide compared with placebo.

Pulmonary conditions—Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.

Deaths in subjects with mild cognitive impairment (MCI)—In controlled trials in elderly subjects with MCI, 13 subjects on RAZADYNE (n=1026) and 1 subject on placebo (n=1022) died of various causes. About half of the RAZADYNE® deaths appeared to result from various vascular causes (myocardial infarction, stroke, and sudden death). RAZADYNE and RAZADYNE ER are not indicated for the treatment of MCI.

Hepatic or renal impairment—In patients with moderately impaired hepatic or renal function, dose titration should proceed cautiously. The use of RAZADYNE or RAZADYNE ER in patients with severe hepatic impairment or severely impaired renal function (CLcr <9 mL/min) is not recommended.

4Important Information About Drug-Drug Interactions With RAZADYNE ER4

RAZADYNE ER has multiple metabolic pathways and is renally excreted; CYP2D6 and CYP3A4 are the major enzymes involved in the metabolism. Drugs that are potent inhibitors for CYP2D6 may increase the area under the curve (AUC). RAZADYNE ER has the potential to interfere with the activity of anticholinergic medications. For a complete list of medications studied, refer to the full Prescribing Information.

  • RAZADYNE ER [Prescribing information]. Titusville, NJ:Ortho-McNeil Neurologics, Inc.;2006.
  • Samochocki M, Zerlin M, Jostock R, et al. Galantamine is an allosterically potentiating ligand of the human α4/β2 nAChR. Acta Neurol Scand. 2000;176(suppl):68-73.
  • Brodaty H, Corey-Bloom J, Potocnik FCV, Truyen L, Gold M, Damaraju CRV. Galantamine prolonged-release formulation in the treatment of mild to moderate Alzheimer's disease. Dement Geriatr Cogn Disord. 2005;20:120-132.
  • RAZADYNE ER [Prescribing information]. Titusville, NJ:Ortho-McNeil Neurologics, Inc.;2006.